Sotalol Hydrochloride
SOTALOL HYDROCHLORIDE TABLETS, USP Rx only
Approved
Approval ID
d288de0a-913d-4617-aa47-c6201ebf2a0d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 4, 2016
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sotalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-2702
Application NumberANDA075563
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2016
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SOTALOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT